Distal Radius FracturesNCT06913933
Static vs. Dynamic Progressive Splinting for Persistent Wrist Stiffness After DRF
A study testing Static Progressive Splinting for Persistent Wrist Stiffness and Dynamic Splinting for Persistent Wrist Stiffness in people with Distal Radius Fractures, run by Al Hayah University In Cairo at 1 site in Egypt.
Trial summary
This randomized controlled trial will compare the effectiveness of static progressive splinting versus dynamic splinting for treating persistent wrist stiffness in adults ≥18 years old at least 8 weeks post distal radius fracture (DRF) injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Static Progressive Splinting for Persistent Wrist Stiffness and Dynamic Splinting for Persistent Wrist Stiffness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Apr 2025to 17 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older. At least 8 weeks post distal radius fracture (operative or nonoperative) who have completed standard rehabilitation.
- Demonstrated persistent wrist stiffness with ≤50% of contralateral wrist extension or flexion.
- Capable of providing written informed consent and complying with study procedures
Who cannot join
- Presence of complex regional pain syndrome (CRPS) or active fracture healing issues.
- History of significant wrist pathology unrelated to the DRF. Uncontrolled medical conditions that would interfere with splint application or therapy.
- Known skin conditions or allergies that preclude orthosis use. Inability or unwillingness to adhere to the intervention protocol or follow-up schedule.
- Pregnant or breastfeeding individuals.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Al Hayah University
Cairo, 12311
Mohamed ElMeligie, Ph.D, 01159880001 ext. +20, mohamed.elmeligie@ahuc.edu.eg
About this study
Official title: A Two-Arm, Parallel-Group Randomized Controlled Trial Comparing Static Progressive Splinting Versus Dynamic Splinting for Improving Wrist PROM/AROM in Patients With Persistent Post-DRF Stiffness
This randomized controlled trial will compare the effectiveness of static progressive splinting versus dynamic splinting for treating persistent wrist stiffness in adults ≥18 years old at least 8 weeks post distal radius fracture (DRF) injury. Both splinting modalities are provided as an adjunct to one weekly supervised therapy session over a 6-week period. The primary outcomes are wrist active and passive range of motion (AROM/PROM) measured using goniometry, with secondary outcomes including patient-reported wrist function (PRWE), overall satisfaction, and adverse events.
- Conditions
- Distal Radius Fractures
- Being tested
- Static Progressive Splinting for Persistent Wrist Stiffness, Dynamic Splinting for Persistent Wrist Stiffness
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static Progressive Splinting for Persistent Wrist StiffnessBehavioural
A commercially available static progressive splint with a turnbuckle mechanism allowing fine-tuned adjustments in wrist flexion and extension.
Instructional materials for home use including written guidelines and an adjustment log.
Dynamic Splinting for Persistent Wrist StiffnessBehavioural
Materials:
A commercially available dynamic (spring-loaded) splint designed for the wrist. An instructional manual and daily usage log for participants.
| Study group | Role | What they receive |
|---|---|---|
| Static Progressive Splinting Group (SPSG) | Experimental | Participants in this group receive static progressive splinting using a commercial splint that allows incremental adjustment through a turnbuckle design. This splint is used to gradually increase wrist extension and/or flexion, tailored to the patient's stiffness pattern, alongside a once-weekly supervised therapy session. Receives: Behavioral: Static Progressive Splinting for Persistent Wrist Stiffness |
| Dynamic Splinting Group (DSG) | Experimental | Participants in this group receive dynamic splinting using a commercial device equipped with elastic tension (spring-loaded) that provides a constant dynamic stretch to the wrist. This intervention is delivered alongside a weekly supervised therapy session. Receives: Behavioral: Dynamic Splinting for Persistent Wrist Stiffness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrist Active and Passive Range of Motion (AROM/PROM)
Measured using a standard goniometer, improvements in wrist flexion and extension (in degrees) are the primary indicators of treatment efficacy.
Measured: Assessed at baseline, 6 weeks (post-intervention), and 3 months follow-up.
Secondary outcomes (3)
Patient-Rated Wrist Evaluation (PRWE)
The PRWE questionnaire assesses wrist pain and disability, with lower scores indicating better functional status.
Measured: Assessed at baseline and at 6 weeks post-intervention.
Patient Satisfaction
A standardized satisfaction survey measuring patients' perceived improvement and overall satisfaction with the orthotic intervention.
Measured: Collected at 6 weeks and 3 months post-intervention.
Incidence of Adverse Events
Incidence and severity of adverse events such as skin breakdown, discomfort, or pain (≥4/10) associated with splint usage.
Measured: Continuously monitored from baseline to the 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start17 Apr 2025 (estimated)
- Primary completion17 Apr 2026 (estimated)
- Study completion17 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two parallel arms. One arm will receive a static progressive splint, and the other a dynamic splint, each used in addition to a weekly supervised therapy session. The splints are used to address persistent ROM limitations after conventional therapy has plateaued.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Hayah University In Cairo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913933
- Sponsor's protocol ID
- SPDS2025-03
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Arm, Parallel-Group Randomized Controlled Trial Comparing Static Progressive Splinting Versus Dynamic Splinting for Improving Wrist PROM/AROM in Patients With Persistent Post-DRF Stiffness
- ClinicalTrials.gov ID
- NCT06913933
- Acronym / sponsor ID
- SPDS2025-03
- Conditions
- Distal Radius Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al Hayah University In CairoUniversity, hospital or other
- Study start
- 17 Apr 2025 (estimated)
- Primary completion
- 17 Apr 2026 (estimated)
- Study completion
- 17 Apr 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will compare the effectiveness of static progressive splinting versus dynamic splinting for treating persistent wrist stiffness in adults ≥18 years old at least 8 weeks post distal radius fracture (DRF) injury. Both splinting modalities are provided as an adjunct to one weekly supervised therapy session over a 6-week period. The primary outcomes are wrist active and passive range of motion (AROM/PROM) measured using goniometry, with secondary outcomes including patient-reported wrist function (PRWE), overall satisfaction, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel arms. One arm will receive a static progressive splint, and the other a dynamic splint, each used in addition to a weekly supervised therapy session. The splints are used to address persistent ROM limitations after conventional therapy has plateaued.
| Arm | Type | Receives |
|---|---|---|
| Static Progressive Splinting Group (SPSG) | Experimental | Behavioral: Static Progressive Splinting for Persistent Wrist StiffnessParticipants in this group receive static progressive splinting using a commercial splint that allows incremental adjustment through a turnbuckle design. This splint is used to gradually increase wrist extension and/or flexion, tailored to the patient's stiffness pattern, alongside a once-weekly supervised therapy session. |
| Dynamic Splinting Group (DSG) | Experimental | Behavioral: Dynamic Splinting for Persistent Wrist StiffnessParticipants in this group receive dynamic splinting using a commercial device equipped with elastic tension (spring-loaded) that provides a constant dynamic stretch to the wrist. This intervention is delivered alongside a weekly supervised therapy session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older. At least 8 weeks post distal radius fracture (operative or nonoperative) who have completed standard rehabilitation.
- Demonstrated persistent wrist stiffness with ≤50% of contralateral wrist extension or flexion.
- Capable of providing written informed consent and complying with study procedures
Key exclusion criteria (4 listed)
- Presence of complex regional pain syndrome (CRPS) or active fracture healing issues.
- History of significant wrist pathology unrelated to the DRF. Uncontrolled medical conditions that would interfere with splint application or therapy.
- Known skin conditions or allergies that preclude orthosis use. Inability or unwillingness to adhere to the intervention protocol or follow-up schedule.
- Pregnant or breastfeeding individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static Progressive Splinting for Persistent Wrist StiffnessA commercially available static progressive splint with a turnbuckle mechanism allowing fine-tuned adjustments in wrist flexion and extension. Instructional materials for home use including written guidelines and an adjustment log. | Behavioural | Static Progressive Splinting Group (SPSG) |
| Dynamic Splinting for Persistent Wrist StiffnessMaterials: A commercially available dynamic (spring-loaded) splint designed for the wrist. An instructional manual and daily usage log for participants. | Behavioural | Dynamic Splinting Group (DSG) |
Primary outcome
Wrist Active and Passive Range of Motion (AROM/PROM)
Time frame: Assessed at baseline, 6 weeks (post-intervention), and 3 months follow-up.
Measured using a standard goniometer, improvements in wrist flexion and extension (in degrees) are the primary indicators of treatment efficacy.
3 secondary outcomes
Patient-Rated Wrist Evaluation (PRWE)
Time frame: Assessed at baseline and at 6 weeks post-intervention.
Patient Satisfaction
Time frame: Collected at 6 weeks and 3 months post-intervention.
Incidence of Adverse Events
Time frame: Continuously monitored from baseline to the 3-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static Progressive Splinting for Persistent Wrist Stiffness and Dynamic Splinting for Persistent Wrist Stiffness in people with Distal Radius Fractures, run by Al Hayah University In Cairo at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrist Active and Passive Range of Motion (AROM/PROM) (time frame: Assessed at baseline, 6 weeks (post-intervention), and 3 months follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.